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Medtronic Recalls Certain Insulin Pumps; FDA Issues Warning

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Irish medical technology company Medtronic plc., which generates most of its sales from the U.S., has recalled some of MiniMed Insulin Pumps for fear of hacking.

The recalled products include MiniMed 508 Insulin Pump and MiniMed Paradigm Series Insulin Pumps. The U.S. Food and Drug Administration issued a warning that these insulin pumps hold potential cybersecurity risks.

In a patient letter, Medtronic stated that the recalled insulin pumps are designed to communicate using a wireless radio frequency or RF with other devices. These devices include blood glucose meters, glucose sensor transmitters, and CareLink USB devices.

It has been warned that an unauthorized person could potentially connect wirelessly to a nearby insulin pump to change its settings to either over-deliver insulin or to stop insulin delivery. This could lead to hypoglycemia or hyperglycemia and diabetic ketoacidosis.

Till now, there were no reports of unauthorized persons changing settings or controlling insulin delivery.

The regulator noted that the company cannot update these models, and recommended that patients using these models should change their insulin pump to newer models with increased cybersecurity protection. Medtronic considers the MiniMed 670G insulin pump as the one with increased protection.

Until getting a replacement, the company urged patients to take certain precautions. The company asked to keep insulin pump and the connected devices under self control all the time, and to not share pump serial number. It also prescribed to connect Medtronic insulin pump to other Medtronic devices and software only, and to disconnect USB device when not in use.

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